Tracheotomy device and method of use

ABSTRACT

A device for performing a tracheotomy on a patient without the assistance of a medical professional. The device may include one or more mechanical arms that cause a blade to create an incision, cause a dilating tool to dilate the incision, and cause a tracheotomy tube to be inserted into the incision. The device may further include a scanner and/or a hollow needle connected to an air pressure sensor that may be used to detect whether the device is aligned with the patient&#39;s airway.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.17/487,173, filed on Sep. 28, 2021, which is a continuation of U.S.patent application Ser. No. 17/182,505, filed on Feb. 23, 2021. Theentire contents of those applications are incorporated herein byreference.

BACKGROUND OF THE INVENTION

A tracheotomy is a surgical procedure in which an incision (a“tracheostomy”) is made in the front of the neck, opening a directairway (hole or stoma) in the trachea (windpipe). A breathing tube (a“tracheotomy tube”) is placed through the incision and into the tracheato keep the incision open for breathing. After a tracheotomy procedureis completed, breathing is done through the tracheotomy tube rather thanthrough the nose and mouth.

A tracheotomy may be performed for a variety of reasons, including: (1)emergency airway access, (2) airway access for prolonged mechanicalventilation, (3) functional or mechanical upper airway obstruction(e.g., obstruction caused by choking on food or other object), or (4)decreased/incompetent clearance of tracheobronchial secretions. In thecase of an emergency such as a traumatic injury to the face or neck, aperson's airway may be suddenly blocked by swelling or blood. Atracheotomy may need to be done quickly to re-establish the airway. Atracheotomy may also be performed to address acute angioedema andinflammation of the head and neck.

A tracheotomy tube may include a cuff, an inflatable balloon at the endof the tube, to secure the tracheotomy tube in place, and to prevent airfrom leaking out. A cuff may also help prevent saliva and othersecretions and swallowed liquids from traveling to the lungs.

Although the airway of most persons is aligned with the center of theirneck, the airway may be located off-center. Accordingly, locating theairway is typically performed before an incision is made. Once theairway is located, a transverse (horizontal) incision may be made abovethe suprasternal notch, or a vertical incision may be made in themidline of the neck from the thyroid cartilage to just above thesuprasternal notch.

Skin, subcutaneous tissue, and strap muscles may be retracted aside toexpose the thyroid isthmus, which can be cut or retracted upwards. Thetrachea may be cut open, either through the space between cartilagerings or vertically across multiple rings. Once the incision is made, aproperly sized tube is inserted. The tracheotomy apparatus may then beattached to the neck with, for example, tracheotomy ties and/or skinsutures.

However, a person may require a tracheotomy when a medical professionalis not available to perform the surgical procedure. For example, aperson choking in a restaurant who does not respond to other measures,such as the Heimlich maneuver, may suffocate from the blockage in theirthroat if a tracheotomy is not performed. As another example, militarypersonnel during wartime deployment may suffer an injury requiring atracheotomy, but may not have access to a medical professional who canperform the procedure.

There is therefore a need for a device and methods that can be used toperform a tracheotomy in an emergency when a medical professional is notavailable to perform the procedure.

SUMMARY OF THE INVENTION

The present invention is directed to a device capable of performing atracheotomy procedure.

It is an object of the present invention to provide a portable devicethat may be used to perform a tracheotomy procedure without theassistance of a medical professional.

It is a further object of the present invention to provide a portabledevice capable of causing the tracheotomy tube to be aligned with theairway in which the tracheotomy tube is to be inserted. Alignment may beachieved by matching the shape or contour of the front wall of thedevice, or an indentation in the front wall of the device, with theouter surface of the throat in which the tracheotomy tube is to beinserted. Additionally or alternatively, the device may include a hollowneedle that may be inserted into the throat and used to detect thelocation of the airway. For example, an air pressure sensor connected tothe needle may be used to sense a change in air pressure, indicatingthat the needle has penetrated the airway. For example, the air pressuresensor may be electronic communication with the controller, and datafrom the air pressure sensor may be transmitted to the controller. Thecontroller may then determine whether data from the air pressure sensorindicates a change in pressure. If no change in air pressure isdetected, or if a change in air pressure is detected but below apredetermine amount or predetermined percentage change, the needle maybe repositioned one or more time until the airway is penetrated and achange in air pressure (or change in pressure above a predeterminedamount or predetermined percentage) is detected.

A device in accordance with the present invention may include one ormore mechanical arms that may be used to create an incision in apatient's neck with a blade, dilate the incision with a dilating tool,and/or insert a tracheotomy tube into the incision.

Numerous variations may be practiced in the preferred embodiment.

BRIEF DESCRIPTION OF THE DRAWINGS

A further understanding of the invention can be obtained by reference toexemplary embodiments set forth in the illustrations of the accompanyingdrawings. Although the illustrated embodiments are merely exemplary ofsystems, methods, and apparatuses for carrying out the invention, boththe organization and method of operation of the invention, in general,together with further objectives and advantages thereof, may be moreeasily understood by reference to the drawings and the followingdescription. Like reference numbers generally refer to like features(e.g., functionally similar and/or structurally similar elements).

The drawings are not necessarily depicted to scale; in some instances,various aspects of the subject matter disclosed herein may be shownexaggerated or enlarged in the drawings to facilitate an understandingof different features. Also, the drawings are not intended to limit thescope of this invention, which is set forth with particularity in theclaims as appended hereto or as subsequently amended, but merely toclarify and exemplify the invention.

FIG. 1 depicts an exemplary device in accordance with the presentinvention;

FIG. 2 depicts an exemplary device in accordance with the presentinvention;

FIG. 3A depicts an interior region of an exemplary device in accordancewith the present invention;

FIG. 3B depicts an interior region of an exemplary device in accordancewith the present invention;

FIG. 3C depicts an interior region of an exemplary device in accordancewith the present invention;

FIG. 4A depicts a tool in accordance with the present invention;

FIG. 4B depicts a tool in accordance with the present invention;

FIG. 5A depicts a mechanical arm and tools attached thereto inaccordance with the present invention;

FIG. 5B depicts a mechanical arm and tools attached thereto inaccordance with the present invention;

FIG. 5C depicts tools in accordance with the present invention;

FIG. 5D depicts a tracheotomy tube in accordance with the presentinvention;

FIG. 6A is a flowchart depicting operation of an exemplary device inaccordance with the present invention;

FIG. 6B is a flowchart depicting operation of an exemplary device inaccordance with the present invention.

DETAILED DESCRIPTION OF THE INVENTION

The invention may be understood more readily by reference to thefollowing detailed descriptions of embodiments of the invention.However, techniques, systems, and operating structures in accordancewith the invention may be embodied in a wide variety of forms and modes,some of which may be quite different from those in the disclosedembodiments. Also, the features and elements disclosed herein may becombined to form various combinations without exclusivity, unlessexpressly stated otherwise. Consequently, the specific structural andfunctional details disclosed herein are merely representative. Yet, inthat regard, they are deemed to afford the best embodiments for purposesof disclosure and to provide a basis for the claims herein, which definethe scope of the invention. It should also be noted that, as used in thespecification and the appended claims, the singular forms “a”, “an”, and“the” include plural referents unless the context clearly indicatesotherwise.

Use of the term “exemplary” means illustrative or by way of example, andany reference herein to “the invention” is not intended to restrict orlimit the invention to the exact features or steps of any one or more ofthe exemplary embodiments disclosed in the present specification. Also,repeated use of the phrase “in one embodiment,” “in an exemplaryembodiment,” or similar phrases do not necessarily refer to the sameembodiment, although they may. It is also noted that terms like“preferably,” “commonly,” and “typically,” are not used herein to limitthe scope of the claimed invention or to imply that certain features arecritical, essential, or even important to the structure or function ofthe claimed invention. Rather, those terms are merely intended tohighlight alternative or additional features that may or may not be usedin a particular embodiment of the present invention.

For exemplary methods or processes of the invention, the sequence and/orarrangement of steps described herein are illustrative and notrestrictive. Accordingly, it should be understood that, although stepsof various processes or methods may be shown and described as being in asequence or temporal arrangement, the steps of any such processes ormethods are not limited to being carried out in any particular sequenceor arrangement, absent an indication otherwise. Indeed, the steps insuch processes or methods generally may be carried out in variousdifferent sequences and arrangements while still falling within thescope of the present invention.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention belongs. Although any methods andmaterials similar or equivalent to those described herein can be used inthe practice or testing of the present invention, some potential andpreferred methods and materials are now described.

The terms “patient” and “user” as recited herein refer to a person onwhom the methods disclosed herein are performed and/or a person on whomthe devices disclosed herein are used. The term “patient” is notintended to be limited to a person under the care of a medicalprofessional or a person treated in a hospital, doctor's office, or anyother medical care facility.

FIG. 1 depicts an exemplary portable tracheotomy device (100) inaccordance with the present invention. Portable tracheotomy device (100)includes a housing (110). Housing (110) may have a front wall (120) anda back wall (130). Front wall (120) and/or back wall (130) may be curvedso as to follow the contour of a person's neck.

Attached to housing (110) may be one or more attaching elements (140,150). Each attaching element (140, 150) may be a strap extend from afirst edge (142, 152) attached to housing (110), to a second edge (144,154). Attaching elements (140, 150) may be capable of wrapping around aperson's neck so that second end (142) of first attaching element (140)and second end (152) of second attaching element (150) may be joinedtogether behind the person's neck. One or both of the second ends (142,152) may have one or more joining elements (146, 156), such as one ormore strips of hook and loop material, an adhesive, one or more snaps,and/or one or more clips that may be used to connect or releasably jointhe second ends (142, 152) together.

FIG. 2 shows an alternative embodiment of a portable tracheotomy device(200) having housing (210). Housing (210) of portable tracheotomy device(200) has a front wall (220) and back wall (230). Front wall (220) ofportable tracheotomy device (200) includes an indentation (222) that mayfollow the curvature of a person's throat.

Attached to housing (210) may be one or more attaching elements (240),such as a strap, that may be of sufficiently length to wrap around aperson's neck. Each attaching (240) element may extending from a firstend (242) attached to housing (210) to a second end (244). One or morejoining elements (246), such as one or more strips of hook and loopmaterial, an adhesive, one or more snaps, and/or one or more clips,located at or near second end (244) of each attaching element (240) mayconnect to one or more complementary joining elements (248) attached tohousing (210).

Each attaching element (140, 150, 240) may have an airtight chamber(148, 158, 248) that may be inflated. Inflating each airtight chamber(148, 158, 248) may help position the portable tracheotomy device (100,200) relative to a patient's neck, may help position the head of apatient (e.g., may cause a patient's head to tilt backward, may cause apatient's head to face forward), and/or may help immobilize a patient'sneck in case the patient has suffered a spinal injury. One or more aircanisters (not shown) located inside or outside housing (110, 210) maybe connected to each airtight chamber (148, 158, 248) by, for example, atube or needle. Air may then be forced from each air canister into eachairtight chamber (148, 158, 248), causing each airtight chamber (148,158, 248) to inflate. The amount of air in each air canister may belimited so to prevent the airtight chambers (148, 158, 248) fromover-inflating or bursting that may result from receiving too much air.Additionally or alternatively, an air pressure sensor may be attached tothe air canisters and each airtight chamber (148, 158, 248) and maycause the air canisters to stop injecting air into the airtight chambers(148, 158, 248) when the pressure in the airtight chambers (148, 158,248) reaches a predetermined level.

Alternatively, each airtight chamber (148, 158, 248) may be inflatedusing a chemical reaction. For example, each airtight chamber (148, 158,248) may contain a first chemical and a packet (shown as 264 in FIG. 2). Within the packet (264) may be a second chemical. The first andsecond chemicals may be chosen from common chemicals known to quicklygenerate a gas when they come in contact with each other, such as thechemicals commonly used to inflate airbags. Packet (264) may be formedfrom a thin film plastic. Attaching element (240) may be twisted or bentso as to cause packet (264) within airtight chamber (148, 158, 248) tobreak. When packet (264) is broken, the second chemical within packet(264) comes into contact with first chemical, causing the generation ofa gas that may inflate airtight chamber (148, 158, 248).

As shown in FIGS. 1 and 2 , front wall of housing (110, 210) may includean aperture (160, 260). One or more doors (162, 164, 262, 264) may coveraperture (160, 260) before tracheotomy device (100, 200) is used. Whentracheotomy device (100, 200) is used to perform a tracheotomyprocedure, the one or more doors (162, 164, 262, 264) may be opened byhand. Alternatively, a motor (not shown) may be used to open the doors.The motor may be activated by, for example, a button (155, 255) locatedon housing (110, 210). Additionally or alternatively, button (155, 255)may cause the device to perform the other functions disclosed below.

The aperture (160, 260) in front wall (120, 220) of housing (110, 210)may lead to an interior region of housing (110, 210) between front wall(120, 220) and back wall (130, 230). FIG. 3 shows an aperture (360) infront wall (320) of a device (300) in accordance with the presentinvention. Aperture (360) leads to interior region (370). Located withininterior region (370) may be components that may perform the tracheotomyprocedure. For example, within interior region (370) may be a powersource (372) such as a battery, a non-transitory memory (not shown)having a machine-readable medium comprising machine executable code, andone or more processors or controllers (not shown) coupled to the memory.Back wall (130, 230) of housing (110, 210) and/or any other walls ofhousing (110, 210) may have one or more apertures (not shown) in fluidcommunication with interior region (370) to allow air to be exchangedbetween interior region (370) and the surrounding area.

To orient device (100, 200) on the neck of a patient so that theincision may be made at a location where it leads to the patient'sairway, the inner wall (120) and/or indentation (222) on inner wall(220) of device (100, 200) may be aligned with the front of a patient'sthroat before the tracheotomy procedure is performed. As noted above,most patients' airways are aligned at the center of the neck, betweenthe left and right side.

Alternatively, device (100, 200) may include one or more components thatmay be used to ensure that device (100, 200) is properly aligned,preferably before an incision is made. For example, device (100, 200)may include a scanner, such as an ultrasound scanner, that can scan forthe presence or absence of tissue across a cross-section of a patient'sneck. Based on data received from the scanner, the processor orcontroller may use a machine learning algorithm to predict whetherdevice (100, 200) is aligned so that an incision at a particularlocation relative to the device would lead to the patient's airway. Ifthe machine learning algorithm returns a result below a predeterminedthreshold used to assess whether device (100, 200) is properly alignedon the patient's neck, device (100, 200) may emit or transmit a signal,such as an audible or visual signal, indicating that device (100, 200)is not properly aligned. For example, a sound generating device (notshown) such as a speaker or a bell may signal that the device is notproperly aligned, by emitting a spoken message or by sounding a soundsuch as a chime. Alternatively, a display screen (not shown) or a light(not shown) on device (100, 200) may emit a signal indicating whetherdevice (100, 200) is or is not properly aligned. If device (100, 200)emits or transmits a signal indicating that it is not properly aligned,device (100, 200) may be re-oriented on the patient's neck before thetracheotomy procedure is performed.

Additionally or alternatively, device (100, 200) may include other meansfor detecting whether device (100, 200) is aligned with a patient'sairway. For example, referring to FIG. 3A, within interior region (370)may be a an open-tip hollow needle (442), extending longitudinally froma pointed, open tip at a first end to a second end. The open-tip hollowneedle (442) may be, for example, attached to a first mechanical arm(440) which may be attached to a first motor (444) powered by the powersource (370) and configured to move the first mechanical arm (440). Afirst driver (not shown) may be connected to, and configured to drive,the first motor (444). Also within interior region (370) may be an airpressure sensor (446) in fluid communication with the interior of hollowneedle (442) and in electronic communication with the controller.

The device may be configured to extend first end of hollow needle (442)a predetermined distance outside housing (110, 210) at a first location.The air pressure sensor (446) in fluid communication with the interiorof hollow needle (442) may be used to detect a change in air pressureafter hollow needle (442) is extended a predetermined distance (e.g., adistance representing at least the distance at which first end (447) ofhollow needle (442) would pierce the skin of the patient). Datacollected from the air pressure sensor (446) may be used (e.g., by thecontroller) to determine whether there is a change in air pressure inhollow needle (442) above a predetermined amount, above a predeterminedpercentage, or within a predetermined range, indicating hollow needle(442) has been inserted into the patient's airway. If a change in airpressure above a predetermined amount or percentage, or within apredetermined range, is detected, device (100, 200) may be configured toproceed with the tracheotomy procedure at the first location of thepatient's neck.

If an airway is not detected (e.g., if data from the air pressure sensor(446) does not indicate a change in air pressure above a predeterminedamount or within a predetermined range, therefore indicating that hollowneedle (442) has not been inserted into the patient's airway), thedevice may be configured to retract the hollow needle (442) from thepatient's neck, move hollow needle (442) to a second location relativeto the first location on the patient's neck, and extend hollow needle(442) a predetermined distance outside housing (110, 210) at the secondlocation. The second location may be a predetermined distance (e.g., 5millimeters or one centimeter) and in a predetermined direction (e.g.,right, left, up or down) relative to the first location. Once hollowneedled (442) is extended at the second location, data collected fromthe air pressure sensor (446) may again be used by the controller todetermine whether hollow needle (442) has been inserted into thepatient's airway. If an airway is detected, the tracheotomy proceduremay proceed at the second location. If an airway is not detected, thesteps of moving hollow needle (442) to a different location, reinsertinghollow needle (442), and detecting whether hollow needle (442) has beeninserted into the patient's airway may be repeated until the airway isdetected. The repetition of those steps may be limited to apredetermined number of time, such as five times.

Once the procedure proceeds, one or more tools within interior region(370) may be used to create an incision in a patient's neck, dilate theincision, and/or insert a tracheotomy tube. For example, referring againto FIG. 3A, within interior region (370) may be a second mechanical arm(430), a tracheotomy tube (432) attached to second mechanical arm (430),and a second motor (434) powered by power source (370) and configured tomove second mechanical arm (430). Also within interior region (370) maybe a second driver (not shown), configured to drive second motor (434).Tracheotomy tube (432) may extend from a first end (433) to a second end(435). First end (433) of tracheotomy tube (432) may be tapered.Tracheotomy tube (432) may include flanges (438) that may extend outwardonce the tracheotomy tube (432) is inserted into the incision,preventing the tracheotomy tube (432) from inadvertently sliding out ofthe incision. Tracheotomy tube (432) may also include an inflatable cuff(439) commonly found on tracheotomy tubes. Inflatable cuff (439) may beinflated to secure tracheotomy tube (432) in place.

Device (100, 200) may be configured to extend tracheotomy tube (432)through aperture (160, 260), outside housing (110, 210), and toward thepatient's neck. First end (433) of tracheotomy tube (432) may be sharp,rigid, and/or tapered to help the tracheotomy tube (432) to penetrateinto the patient's neck until first end (433) reaches the patient'sairway. First end (433) may have a cross-section in the shape of acircle, and device (100, 200) may rotate tracheotomy tube (432) about anaxis extending through the center of, and orthogonal to, that circularcross-section as it is penetrating the patient's neck to help facilitateinsertion of tracheotomy tube (432). Tracheotomy tube (432) may berotated in one direction (clockwise or counter clockwise), ortracheotomy tube (432) may be rotated in one direction and then in thereverse direction once or a plurality of times.

Hollow needle (442) may be removed from the patient's neck beforetracheotomy tube (432) is inserted. Alternatively, hollow needle (442)may remain inserted in the patient's neck while tracheotomy tube (432)is inserted, and thereby used as a guide for inserting tracheotomy tube(432) into the patient's airway. For example, if hollow needle (442)remains in the patient's neck, it may act as a guide by slidingtracheotomy tube (432) over hollow needle (442) as tracheotomy tube(432) is inserted into the patient's neck. As shown in FIG. 3B, to allowhollow needle (442) to serve as a guide for tracheotomy tube (432),before the device (100, 200 is activated), hollow needle (442) may beinserted through tracheotomy tube (432). In addition, first mechanicalarm (440) and/or first motor (444) may be attached to second mechanicalarm (430) and or second motor (434).

Alternatively, an incision may be made in the patient's neck beforetracheotomy tube (442) is inserted. Referring to FIG. 3C, a thirdmechanical arm (410) and a blade (412) attached to third mechanical arm(410) may be located within interior region (370). Blade (412) may beshaped like a scalpel blade or may have another shape, such as acircular blade. Attached to third mechanical arm (410) may be a thirdmotor (414). Third motor (414) may be powered by power source (372) andconfigured to move third mechanical arm (410). A third driver (notshown) may be attached to third motor (414) and configured to drivethird motor (414). Device (100, 200) may be configured to extend blade(412) through aperture (160, 260), outside housing (110, 210), andtoward the patient's neck, creating an incision in the patient's neck.Device (100, 200) may be further configured to move blade (412) awayfrom the location of the incision and/or retract the blade into interiorregion (370) after the incision is made. Device (100, 200) may befurther configured to insert first end (433) of tracheotomy tube (432)into the incision made by blade (412) after the incision is made.

Referring again to FIG. 3C, also within interior region (370) may be afourth mechanical arm (420), a dilating tool (422) attached to thefourth mechanical arm (420), a fourth motor (424) powered by the powersource (372) and configured to move fourth mechanical arm (420), and afourth driver (not shown) configured to drive the fourth motor (424).Dilating tool (422) may be used to expand the incision to facilitateinserting tracheotomy tube (432) in to the patient's airway.

As shown in FIG. 4A, dilating tool (422) may, for example, have theshape of a cone. Alternatively, the dilating tool may have a structureand operate in a manner similar to a chuck on a power drill. Forexample, as shown in FIG. 4B, dilating tool (462) may have a pluralityof jaws (464) that may be arranged around central axis (466). An upperportion (465) of each jaw (464) may be threaded and may be angled awayfrom central axis (466). A sleeve (468) may surround all or part of jaws(464). Rotating sleeve (468) may cause threads located therein to sliderelative to the threaded portion of each jaw (464), causing the jaws tomove toward or away from central axis (466).

To dilate an incision made by blade (412), device (100, 200) may beconfigured to extend dilating tool (422, 462) through aperture (160,260), outside housing (110, 210), and toward the incision. If dilatingtool (422) is shaped like a cone, the tip of the cone may be insertedinto the incision. As dilating tool (422) is pushed further into theincision, the incision may be expanded. If dilating tool (462) has jaws(464) similar to a power drill chuck, the jaws (464) may be insertedinto the incision created by blade (412), and then jaws (464) may beseparated to dilate the incision. Device (100, 200) may be furtherconfigured to move the dilating tool (422, 462) away from the incisionand/or retract dilating tool (422, 462) into interior region (370) afterthe incision is dilated.

Each dilating tool may be capable of cauterizing the incision to inhibitblood from flowing from the incision into the airway. For example, thedilating tool may be connected to the power source. As the dilating toolis inserted into the incision, an electric charge sufficient tocauterize the incision may be delivered from the power source to theouter surface of the dilating tool. The electric charge may be deliveredmultiple times, and may be delivered at predetermined distance intervalsas the dilating tool is inserted into the incision. For example, anelectric charge may be applied each time the dilating tool is insertedan additional two millimeters. Similarly, an electrical charge may beapplied to the tracheotomy tube.

Device (100, 200) may include separate mechanical arms to deploy each ofthe tools used for the tracheotomy procedure, e.g., the hollow needle,the blade, the dilating tool, and the tracheotomy tube. Alternatively,one or more of the tools may be stored within the interior region of thedevice. One or more mechanical arms may deploy a plurality of tools byemploying a first tool, detaching from the first tool (e.g. by storingthe tool in the device), attaching to a second tool, and deploying thesecond tool. In that way, a single mechanical arm may be used to deploytwo, three, or all of the tools. For example, a single mechanical armattached to a blade may be moved so as to use the blade to make anincision in a patient's neck, may disengage from the blade and attach toa dilating tool, may position the dilating tool so as to cause theincision to be dilated, may disengage from the dilating tool andattached to a tracheotomy tube and may insert the tracheotomy tubethrough the incision.

Alternatively a plurality of the tools used to perform the procedure maybe attached to one arm. For example, as shown in FIG. 5A, blade (512),dilating tool (522), and/or hollow needle (546) may be attached to thesame mechanical arm (510). Once device (100, 200) is positioned on apatient's neck—which may include aligning the curvature of the frontwall (120) or indentation (222) with the front of a patient's neck,using a scanner to detect an airway and/or using a hollow needle todetect a change in air pressure as discussed above—mechanical arm (510)may be rotated to orient and use each tool in sequence to perform thetracheotomy procedure. For example, mechanical arm (510) may be orientedfirst so that direction “x” is toward the patient's neck to inserthollow needle (546) into the patient's neck. Mechanical arm (510) maythen be oriented so that direction (y) is toward the patient's neck sothat blade (512) may be used to make an incision. Mechanical arm (510)may then be oriented so that direction (z) is toward the patient's neckso dilating tool (522) may be used to dilate the incision.

Alternatively, as shown in FIG. 5B, blade (512), dilating tool (522),and/or tracheotomy tube (532) may be attached to the same mechanical arm(510). Once device (100, 200) is positioned on a patient's neck,mechanical arm (510) may be rotated to orient and use each tool insequence to perform the tracheotomy procedure. For example, mechanicalarm (510) may be oriented first so that direction “a” is toward thepatient's neck so that blade (512) may be used to make an incision.Mechanical arm (510) may then be oriented so that direction (b) istoward the patient's neck so dilating tool (522) may be used to dilatethe incision. Mechanical arm (510) may then be oriented so thatdirection (c) is toward the patient's neck so the tracheotomy tube maybe inserted into the incision.

A device in accordance with the present invention may also combine oneor more of the tools described above, including the blade, dilatingtool, hollow needle, and/or tracheotomy tube. For example, as shown inFIG. 5C, the blade (513) and dilating tool (523) may be combined into asingle tool. Blade (513) may then be used to make an incision, and blade(513) may be extended into the incision so that dilating tool (523) maydilate the incision.

Alternatively, as shown in FIG. 5D, a cutting edge (514) may be includedat the leading edge (533) of a tracheotomy tube (532). Once device (100,200) is positioned on a patient's neck, cutting edge (514) may be usedto make an incision, and then leading edge (533) of tracheotomy tube(532) may be inserted into the patient's airway. Alternatively oradditionally, leading edge of tracheotomy tube (532) may be tapered tofacilitate insertion of tracheotomy tube (532) without using a separatedilating tool. If tracheotomy tube (532) is sufficiently tapered,leading edge (533) of tracheotomy tube may be inserted into thepatient's throat without first using cutting edge (514) or a blade tomake an incision.

Also within interior region (370) may be a vessel (450) having aninternal chamber (452) and a dispensing nozzle (454). Attached todispensing nozzle (454) and electronically connected to one or morecontrollers may be an actuator (456). Actuator may be capable ofactivating (e.g., depressing) dispensing nozzle (454) upon receiving asignal from the one or more controllers. Located within internal chamber(452) of vessel (450) may be a topical anesthetic and/or a disinfectant.Before an incision is made by blade (412), a signal may be sent from theone or more controllers to actuator (456), causing the dispensing nozzle(454) to dispense the contents of vessel (450). Dispensing adisinfectant may help prevent an infection. Dispensing an anesthetic mayhelp alleviate the pain cause by the incision.

FIG. 6A is a flowchart depicting an exemplary sequence of operations fora device in accordance with the present invention. The sequence ofoperations may be initiated by, for example, depressing a button (155,255) on the device. At Step (600), the device may be positioned on theneck of the person on whom the tracheotomy procedure is to be performed(“the patient”). Front wall of the housing of the device may be curvedor may have a curved indentation that matches or is similar to thecontour of a person's neck. One or more straps may be used to secure thedevice to the patient's neck. The straps may have airtight chambers thatmay be inflated to secure the device to the patient's neck and/or toimmobilize the patient's neck.

At Step (610), the airtight chambers may be inflated by, for example,injecting air into the airtight chambers from an air canister that maybe located outside the housing of the device, or inside the housing ofthe device. Alternative, the airtight chambers may be inflated by achemical reaction between two chemicals. One chemical may be locatedwithin the airtight chamber, and a second chemical may be located withina packet inside the airtight chamber. When the packet is broken, thechemicals may contact each other, generating a gas.

At Step (620), a signal may be sent to an actuator within the devicecausing the contents of a vessel within the device to be applied to theneck of the patient. The contents of the vessel may include ananesthetic and/or a disinfectant.

At Step (630), the open tip of a hollow needle may be extended outsidethe housing of the device at a first location. At Step (640), an airpressure sensor in fluid communication with the interior of the hollowneedle may be used to detect a change in air pressure indicating whetherair is flowing into needle from the open tip of the needle. A change inair pressure above a predetermined amount or predetermined percentage orwithin a predetermined range may indicate that the open tip of thehollow needle has reached the patient's airway. Regardless of whetherthe flow of air is detected by the air pressure sensor, the method mayproceed to Step (670).

Alternatively, if a change in air pressure above a predetermined amountis not detected by the air pressure sensor, indicating that the open tipof the hollow needle did not reach the patient's airway, the open tip ofthe hollow needle may be retracted and extended from the housing of thedevice at a second location. For example, the second location may be onecentimeter to the left, right, above, or below the first location. If achange in air pressure is not detected at the second location, the opentip of the hollow needle may be shifted again to a different locationthat is at a predetermined distance and orientation from the secondlocation. Repositioning of the needle may continue until a change in airpressure above a predetermined amount or percentage or within apredetermined range is detected.

At Step (670), a tracheotomy tube may be extended outside the housing.The tracheotomy tube may be extended with sufficient force to pierce thepatient's neck and extend into the patient's airway. The tracheotomytube may be inserted around the hollow needle, thereby using the hollowneedle as a guide.

At Step (680) a cuff on the tracheotomy tube may be inflated.Additionally or alternatively, flanges on the tracheotomy tube may beextended to help ensure that the tracheotomy tube remains in place.

Referring to FIG. 6B, as an alternative method, an insertion may bemade, and the insertion may be dilated before the tracheotomy tube isinserted. For example, Steps (600), (610), (620), (630), (640), (670),and (680) may be the same as described above. But immediately followingStep (640), at Step (650) a blade may be extended from the housing,toward the patient's neck to make an incision. At Step (660), a dilatingtool may be extended from the housing to the location where theinsertion was made and used to dilate the incision. Then at Step (670),a tracheotomy tube may be inserted into the dilated incision.

At Step (680) a cuff on the tracheotomy tube may be inflated.Additionally or alternatively, flanges on the tracheotomy tube may beextended to help ensure that the tracheotomy tube remains in place.

While the invention has been described in detail with reference toembodiments for the purposes of making a complete disclosure of theinvention, such embodiments are merely exemplary and are not intended tobe limiting or represent an exhaustive enumeration of all aspects of theinvention. It will be apparent to those of ordinary skill in the artthat numerous changes may be made in such details, and the invention iscapable of being embodied in other forms, without departing from thespirit, essential characteristics, and principles of the invention.Also, the benefits, advantages, solutions to problems, and any elementsthat may allow or facilitate any benefit, advantage, or solution are notto be construed as critical, required, or essential to the invention.The scope of the invention is to be limited only by the appended claims.

What is claimed is:
 1. A method of operating a portable device capableof performing a tracheotomy procedure on a patient, said portable devicehaving a power source; a tracheotomy tube; a scanner; a non-transitorymemory having a machine-readable medium comprising machine executablecode; and a controller coupled to the memory, said method comprising thesteps of: placing the portable device adjacent to the front of apatient's neck; activating the portable device, thereby causing theportable device to, without further intervention from a user of thedevice: use the scanner to determine a location of the patient's airway;and insert at least a portion of the tracheotomy tube into the patient'sairway without any incision having previously been made in the patient'sneck at a location where the tracheotomy tube is inserted.
 2. The methodof claim 1, wherein the scanner is an ultrasound scanner.
 3. The methodof claim 2, wherein the scanner scans for the presence or absence oftissue across a cross-section of the patient's neck.
 4. The method ofclaim 3, further comprising determining from data generated by thescanner whether the device is aligned with the patient's airway.
 5. Themethod of claim 4, further comprising, upon processing said data andbefore inserting the tracheotomy tube into the patient's airway, movingthe tracheotomy tube to a different location.
 6. The method of claim 1,wherein the scanner scans for the presence or absence of tissue across across-section of the patient's neck.
 7. The method of claim 6, furthercomprising determining from data generated by the scanner whether thedevice is aligned with the patient's airway.
 8. The method of claim 7,further comprising, upon processing said data and before inserting thetracheotomy tube into the patient's airway, moving the tracheotomy tubeto a different location.
 9. The method of claim 1, further comprisingdetermining from data generated by the scanner whether the device isaligned with the patient's airway.
 10. The method of claim 9, furthercomprising, upon processing said data and before inserting thetracheotomy tube into the patient's airway, moving the tracheotomy tubeto a different location.